Dermazole Plus shampoo, bottle 50 ml

Pharmacological Properties

Pharmacodynamics. The pharmacological properties of the shampoo are determined by the active substances it contains: ketoconazole and zinc pyrithione.

Ketoconazole, a synthetic derivative of imidazoledioxolane, exhibits fungicidal and fungistatic activity against dermatophytes (Epidermophyton spp., Microsporum spp., Trichophyton spp.), various strains of yeasts and yeast-like fungi (Candida spp., Malassezia furfur – Pitysporum ovale).

Zinc pyrithione, when applied externally, has antimicrobial and antifungal effects; it is effective against streptococci, staphylococci, fungi, and a number of other pathogenic microorganisms. Zinc pyrithione provides the shampoo’s anti-seborrheic effect and acts against dandruff. Ketoconazole shampoo reduces flaking and itching often associated with dandruff, seborrheic dermatitis, and pityriasis versicolor.

Aloe vera powder helps moisturize the hair and enrich it with vitamins and trace elements.

Pharmacokinetics. Specific pharmacokinetic studies of the shampoo have not been conducted, but ketoconazole and zinc pyrithione are known to have minimal systemic absorption when applied externally and do not cause systemic effects.

Indications

Treatment and prevention of fungal infections of the scalp associated with flaking and itching, such as dandruff, seborrheic dermatitis, and localized pityriasis versicolor of the scalp.

Administration

Shake the shampoo well before use.

Apply to wet hair and scalp for 3–5 minutes, then rinse with water.

Contraindications

Hypersensitivity to ketoconazole, zinc pyrithione, or any other component of the product.

Side Effects

Skin and subcutaneous tissue: erythema, burning sensation, itching, acne, contact dermatitis, skin irritation, rash, pustular rash at the application site, urticaria, dry skin, increased flaking, discomfort, hypersensitivity, skin changes.

Hair and scalp: changes in hair structure, increased dryness or oiliness, hair loss (alopecia), hair discoloration (especially in chemically damaged or gray hair), nail discoloration. Cases of natural curly hair becoming straight have been reported.

Nervous system: taste disturbances (dysgeusia), paresthesia, hypersensitivity.

Immune system: hypersensitivity reactions, including anaphylactoid reactions; angioedema.

Eyes: eye irritation, eyelid swelling, increased tearing.

Infections: folliculitis.

Special Precautions

This product is intended for external use only.

Avoid contact with eyes and mucous membranes. In case of contact with eyes, rinse thoroughly with water.

Seborrheic dermatitis and dandruff are often accompanied by increased hair loss, which may persist temporarily during initial treatment.

The product contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g., contact dermatitis) or irritation of eyes and mucous membranes.

Pregnancy and breastfeeding: Use only if the expected benefit outweighs the potential risk.

Children: No clinical experience in children.

Driving: Does not affect the ability to drive or operate machinery.

Interactions

When Dermazole Plus is prescribed to patients who have used topical corticosteroids long term, they should continue corticosteroids and taper them gradually over 2–3 weeks to avoid withdrawal syndrome.

Due to minimal systemic absorption, interactions with other medicinal products are unlikely.

Concurrent use with dermatological preparations containing corticosteroids is not recommended.

Overdose

As the shampoo is intended only for external use and ketoconazole has minimal systemic absorption, overdose is unlikely. In case of accidental ingestion, only supportive and symptomatic treatment is used. Vomiting and gastric lavage should not be induced to avoid aspiration.

Storage Conditions

Store at temperatures not exceeding 25 °C.